A clinical trial sponsor asked Midwinter to develop a sourcing strategy for a Phase III study using the FOLFOX chemotherapy regimen, which consists of three generic medicines. The sponsor had previously conducted a Phase II trial with the same drugs but faced significant supply challenges due to issues with the manufacturers named in their protocol.

The Challenges

Despite selecting what initially seemed like strong sourcing options, the sponsor encountered:

• Manufacturing Delays – Production times were longer than originally quoted.
• Poor Communication – Manufacturers failed to provide timely and transparent updates on delays.

While manufacturing disruptions are sometimes unavoidable, proactive communication and contingency planning are critical to maintaining a stable clinical supply chain. Delays identified early allow for timely intervention and alternative sourcing strategies to be implemented.

Midwinter’s Strategic Approach

To mitigate risks and strengthen the supply chain for the Phase III trial, Midwinter advised a multi-layered sourcing strategy, incorporating flexibility, contingency planning, and proactive vendor selection.

1. Diversification of Manufacturers 

• The protocol should include multiple manufacturers to allow for fallback options (Plan A, B, and C) in case of supply constraints.
• A broader selection of manufacturers reduces dependency on a single supplier and enhances adaptability.

2. Geographic Flexibility 

• Avoid restricting sourcing to a single region. Writing the protocol with flexibility allows for regional adjustments if unexpected supply issues arise.
• This approach ensures greater access to available stock across global markets.

3. Optimized Drug Presentation Selection

• Selecting the most available drug strengths and presentations increases procurement success.
• Midwinter recommended purchasing product strengths that align with market availability, preventing bottlenecks.

4. Vendor Selection Beyond Brand Reputation

• Sponsors should look beyond well-known manufacturers when selecting generic drug suppliers.

Some lesser-known manufacturers may demonstrate:

• Greater willingness to support clinical trials
• Focus on manufacturing certain key products
• Better communication and responsiveness

5. Prioritizing Long-Term Supply Stability Over Cost 

• The lowest-cost drug is not always the best option.
• A mid-trial stockout presents the highest risk and financial burden to a study.
• Investing in reliable and communicative manufacturers reduces the likelihood of costly interruptions.

Results: A Resilient and Collaborative Supply Chain

Midwinter implemented a robust supply strategy, introducing new sourcing pathways and engaging manufacturers that prioritize clinical trials alongside their commercial commitments. This collaborative approach ensured:

• Reliable supply continuity throughout the trial
• Improved vendor communication for proactive problem-solving
• Flexible sourcing options to mitigate risk

By applying Midwinter’s expertise, the sponsor entered Phase III with a resilient, cost-effective, and adaptable supply chain, minimizing the risk of disruption and ensuring the trial remained on track.